Life Science Compliance Update

December

2017

Even Distributors Are Not Immune – AmeriSourceBergen’s Recent Compliance Struggles

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In recent months, AmeriSourceBergen’s (“ABC”) ongoing struggles with compliance about its corporate subsidiaries and wholesale units has been well-publicized. For instance, on August 23, 2017, the United States Department of Justice (“DOJ”) announced a settlement $13.4 Million involving illicit False Claims Act (“FCA”) and kickback billing activities by U.S. Bioservices Corp., a unit of wholesale ABC concerning the medication Exjade. In a separate matter, the DOJ a settlement with ABC to resolve criminal liability relating to illicit business activities by AmeriSouceBergen Specialty Group (“ABSG”), a subsidiary of ABC involving the misbranding and distribution of oncology cancer related medications from a processing facility that was not approved by the U.S. Federal Food and Drug Administration (“FDA”). Both cases highlight the FCA civil, and criminal liability parent companies face for the illicit conduct of their various corporate subsidiaries and entities.


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December

2017

The 21st Century Cures Act Moves One Step Closer to Reality with FDA’s Work Plan

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

With the formal legislative passage of the 21st Century Cures Act (“Act”), a bipartisan effort to expedite research and development and approval of new drugs, the U.S. Food and Drug Administration (“FDA”) is now moving full-steam ahead by making public its legislative implementation work plan in regard to the Act, including a list of agency policy objectives, list of deliverables, and a detailed summary of budget allocations for such Act. Although the FDA’s implementation efforts in this regard are still emerging, it is clear that the Agency is seeking in every way possible to make the Act a new reality for all stakeholders in the life sciences community.


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November

2017

The Expanding Frontier Part 3 – PAGs in Light of the Aegerion Cases

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Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

There is no doubt that Patient Advocacy Groups play an important and substantial role in shaping the healthcare landscape. It also is true that it is not a simple matter for life sciences companies to work with these groups. This article examines the recent trio of cases involving Aegerion to ascertain what it says about the government’s enforcement stance and how that it may shape the future of industry/PAG interactions.


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November

2017

Increasing the Tension – Expanding Patient Access to Investigational Medical Products

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Maureen Lloyd a Health Industries, Risk and Regulatory Director and Dixil Francis a Health Industries, Risk and Regulatory Manager at PWC

Expanding patient access to therapies currently being tested but not yet marketed is both increasingly challenging and important. However, despite the many challenges, changing regulations and industry association guidelines have increased pressure on manufacturers to develop or expand their access to medicines programs. Therefore, it is clear that improving appropriate patient access to investigational medical products remains a prominent objective for the life science industry. This article explores the changing environment surrounding expanded patient access and the practical implications facing life science companies trying to balance competing concerns.


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October

2017

The Never-Ending Saga of Off-label Promotion

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Jenny McVey, Associate Director, FRA Life Sciences

The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as well as the growing need for data-driven medicine, the agency has been under pressure more than ever to update their regulatory position. This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.


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  • March

    2017

    A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.


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    November

    2016

    June

    2016

    The Dreaded Performance Appraisal – How the FDA Is Doing with Medical Devices and the Medical Device Industry

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    Calisha D. Myers, Esq., Staff Writer for Life Science Compliance Update

    The FDA and the GAO both released data on the FDA’s performance in medical device regulation over the last several years. This article takes a close look at this data and compares it with the data available through the FDA’s OpenFDA database. The data shows recalls have increased, but postmarket and postapproval studies have declined.


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    May

    2016

    Smoking It – FDA Proposes Changes to Adequate Labeling Provision in a Tobacco Regulation

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    Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update
    The FDA has proposed changes to “adequate labeling” provisions for drugs and devices. This article sheds light on the proposed change, as well as the potential impact if the proposed rule becomes finalized.


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    March

    2016

    Exploring Strange New Worlds – FDA’s 2016 Program Alignment and Strategic Priorities

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    By: Calisha D. Myers, Esq., Staff Writer – Life Science Compliance Update

    This article provides an overview of the FDA’s initiative to realign programs from location-centered structures and specializations to commodities specializations, and its impact on the implementation of the Food and Drug Administration Safety and Innovation Act (FDASIA).


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